Question 1

What is Formulated Solutions?

Accepted Answer

Formulated Solutions is a U.S.-based contract development and manufacturing organization (CDMO) serving the OTC, prescription, cosmetic, and medical device markets. We operate two GMP-compliant facilities in Largo, Florida and Cleveland, Tennessee, offering full-service support from formulation development through commercial manufacturing and packaging.

Question 2

What is a CDMO, and what role does Formulated Solutions play as one?

Accepted Answer

A CDMO, or contract development and manufacturing organization, partners with brands to develop, scale up, and manufacture products on their behalf. Formulated Solutions serves this role for OTC, Rx, medical device, and cosmetic brands, managing everything from early formulation through commercial-scale production.

Question 3

Where are Formulated Solutions' manufacturing facilities located?

Accepted Answer

Formulated Solutions operates two U.S. manufacturing facilities, located in Largo, Florida and Cleveland, Tennessee, together providing more than 800,000 square feet of GMP production and warehousing space.

Question 4

How long has Formulated Solutions been manufacturing products for its partners?

Accepted Answer

Formulated Solutions brings more than 25 years of manufacturing experience, supporting leading consumer healthcare and pharmaceutical brands across formulation development, technology transfer, and commercial production.

Question 5

What industries and markets does Formulated Solutions serve?

Accepted Answer

Formulated Solutions serves the OTC, prescription, cosmetic, personal care, nutraceutical, and medical device markets, supporting categories such as nasal health, antifungals, pain relief, skin health, and hygiene.

Question 6

What types of companies does Formulated Solutions typically partner with?

Accepted Answer

Formulated Solutions partners with companies of all sizes, from early-stage brands developing a first product to large, globally recognized consumer healthcare companies with established commercial portfolios.

Question 7

Does Formulated Solutions support medical device assembly?

Accepted Answer

Yes. Formulated Solutions supports Class I and Class II medical device assembly.

Question 8

Does Formulated Solutions manufacture natural, clean-label, or "free-from" formulations?

Accepted Answer

Yes. Formulated Solutions' development team supports natural, clean-label, and free-from formulations, developed without ingredients such as parabens, sulfates, or synthetic fragrances, depending on product category and regulatory requirements.

Question 9

Does Formulated Solutions manufacture topical analgesic and pain relief products?

Accepted Answer

Yes. Formulated Solutions has extensive experience developing and manufacturing topical analgesic and pain relief products, including creams, gels, lotions, sprays, foams, roll-ons, and other topical dosage forms. We support products regulated under OTC Monograph, OTC NDA, and prescription (Rx) pathways, providing formulation development, analytical support, scale-up, commercial manufacturing, and packaging. Our expertise includes products containing common analgesic active ingredients as well as combination therapies designed to improve patient experience and product performance.

Question 10

What dosage forms and packaging formats does Formulated Solutions manufacture?

Accepted Answer

Formulated Solutions manufactures a broad range of pharmaceutical dosage forms and packaging formats, including aerosols, nasal sprays, airless bottles, pumps, jars, tubes, rollerballs, Bag-on-Valve (BOV) systems, metered-dose products, and traditional bottles. We help customers select the optimal delivery system based on formulation requirements, patient experience, and commercial objectives while supporting development through commercial production.

Question 11

What makes Formulated Solutions a good fit for brands with complex or specialized delivery system needs?

Accepted Answer

Formulated Solutions specializes in technically demanding delivery systems, including aerosols, bag-on-valve, foams, and nasal sprays, along with specialty formats like vapo-coolant and cryoablation sprays that require precise formulation and process control.

Question 12

What product categories does Formulated Solutions manufacture?

Accepted Answer

What product categories does Formulated Solutions manufacture?

Formulated Solutions develops and manufactures a broad range of prescription (Rx), over-the-counter (OTC), cosmetic, medical device, and personal care products across numerous therapeutic categories.

Our experience includes:

Topical Pain Relief (Analgesics)
Cough & Cold
Nasal Sprays
Acne Treatments
Topical Anesthetics
Hemorrhoid Care
Antifungal Products
Itch & Burn Relief
Medicated Skin Care
Wound Care
Eczema & Psoriasis Treatments
Diaper Care
Wart Care
Medicated Hair Care
Cosmetic Hair Care
Anti-inflammatory Products
Sun Care & Sunscreens
Medicated Shampoo
Insect Bite Treatments
Allergy Relief
Eye Care
Gastrointestinal Liquids
Baby & Child Care
Scar Treatments
And more

From formulation development and analytical testing to commercial manufacturing and packaging, Formulated Solutions provides end-to-end CDMO support across these product categories.

Question 13

What regulatory product categories does Formulated Solutions support?

Accepted Answer

What regulatory product categories does Formulated Solutions support?

Formulated Solutions develops and manufactures products across multiple regulated healthcare and consumer product categories, including:

OTC Monograph Products
OTC NDA Products
Prescription (Rx) Pharmaceuticals
Medical Devices
Cosmetics

Our integrated CDMO capabilities include formulation development, analytical testing, regulatory support, scale-up, commercial manufacturing, and packaging. We work closely with customers to bring products to market across a wide variety of therapeutic categories, dosage forms, and delivery systems.

Question 14

Does Formulated Solutions offer private label / white label manufacturing?

Accepted Answer

Yes. Formulated Solutions offers both contract manufacturing of a brand's proprietary formulation, private label and white label programs using established formulations, giving partners flexibility based on timeline and budget.

Question 15

Can a brand own the exclusive rights to a formulation developed at Formulated Solutions?

Accepted Answer

Yes. Formulation IP developed specifically for a partner can be structured as exclusive to the brand, co-owned, or retained by Formulated Solutions, depending on the development agreement.

Question 16

Does Formulated Solutions work with international brands seeking U.S.-based manufacturing?

Accepted Answer

Yes. Formulated Solutions partners with international brands seeking U.S.-based manufacturing to establish a U.S. supply chain, meet FDA requirements, or enter the U.S. market. We currently ship to 46+ countries worldwide.

Question 17

Does Formulated Solutions require a signed NDA before discussing a new project?

Accepted Answer

Yes. Formulated Solutions routinely signs NDAs with prospective partners before discussing proprietary formulation or technical details, protecting both parties from the earliest conversations.

Question 18

Can prospective partners tour Formulated Solutions' facilities before committing to a program?

Accepted Answer

Yes. Formulated Solutions welcomes prospective partners to tour our Florida and Tennessee facilities as part of the evaluation process, offering direct visibility into our equipment, quality systems, and team.

Question 19

What is Formulated Solutions' overall approach to working with its partners?

Accepted Answer

Formulated Solutions approaches every relationship as a long-term partnership, staying engaged from early formulation through commercial scale-up and ongoing quality and supply performance.

Question 20

How does Formulated Solutions handle product complaints and adverse event reporting?

Accepted Answer

Formulated Solutions maintains documented processes for capturing, investigating, and responding to product complaints and supporting adverse event reporting in coordination with partners.

Question 21

What quality control testing does Formulated Solutions perform on every batch?

Accepted Answer

Every batch moves through documented in-process and finished-product testing, including analytical and, where applicable, microbiological testing, before release under our cGMP-compliant quality system.

Question 22

How often are Formulated Solutions' facilities inspected by regulatory authorities?

Accepted Answer

Formulated Solutions' facilities are subject to periodic inspection by the FDA and applicable domestic + international authorities, and we maintain a sustained, impressive inspection history supported by continuous internal quality oversight.

Question 23

What is the difference between OTC Monograph and OTC NDA products?

Accepted Answer

OTC Monograph products meet FDA pre-approved standards for a category, while OTC NDA products require individual FDA review, typically for ingredients or claims outside the monograph. Formulated Solutions manufactures both.

Question 24

Does Formulated Solutions offer shelf-life and stability testing?

Accepted Answer

Yes. Formulated Solutions maintains in-house real-time and accelerated stability programs to establish and support shelf-life claims for new and existing formulations.

Question 25

How does Formulated Solutions ensure batch traceability and data integrity?

Accepted Answer

Formulated Solutions maintains documented batch records from raw material receipt through finished-product release, supported by validated analytical methods consistent with cGMP data integrity requirements.

Question 26

Does Formulated Solutions offer labeling artwork support?

Accepted Answer

Formulated Solutions manages regulatory label review, ingredient review, and technical justification, and can coordinate with a partner's design resources or outside vendors for artwork production.

Question 27

What is the typical timeline from signed agreement to first commercial shipment?

Accepted Answer

Timelines vary by project type; technology transfer of an existing formulation typically moves faster than ground-up development. Formulated Solutions builds a milestone-based timeline specific to each program early in the partnership.

Question 28

Can Formulated Solutions support multiple SKUs or product lines for the same brand at once?

Accepted Answer

Yes. Formulated Solutions regularly supports multiple SKUs and product lines concurrently across our Florida and Tennessee facilities, managing complex, multi-SKU portfolios with consistent quality.

Question 29

Does Formulated Solutions offer warehousing and logistics support after manufacturing?

Accepted Answer

Formulated Solutions' facilities include GMP-compliant warehousing that supports staging, storage, and coordinated shipment of finished goods aligned with partner distribution needs.

Question 30

How does Formulated Solutions ensure business continuity if one facility experiences a disruption?

Accepted Answer

Formulated Solutions' two U.S. facilities in Largo, Florida and Cleveland, TN provide layered redundancy, allowing many products and processes to be supported at either site if one facility experiences a disruption.

Question 31

Does Formulated Solutions provide packaging design and structural support?

Accepted Answer

Formulated Solutions supports packaging and component selection, matching bottles, tubes, pumps, and aerosol dispensing systems to the formulation, and can coordinate with a partner's design resources for structural or graphic design.

Question 32

Can Formulated Solutions manufacture products using PCR or sustainable packaging?

Accepted Answer

Yes. Formulated Solutions supports packaging formats incorporating post-consumer recycled (PCR) content and works with partners to evaluate sustainable packaging options that meet performance and brand goals.

Question 33

What sustainability initiatives does Formulated Solutions support?

Accepted Answer

Formulated Solutions supports sustainability through PCR packaging options, production efficiency across our facilities, and ongoing evaluation of environmentally responsible formulation and packaging practices.

Question 34

What industry organizations, associations, and trade shows does Formulated Solutions participate in?

Accepted Answer

Formulated Solutions maintains an active presence in the industry through participation in events such as CPHI, CHPA, DCAT, Contract Pharma, SATA, and Cosmoprof, reflecting our ongoing commitment to industry leadership and partnership.

Question 35

What topical dosage forms does Formulated Solutions manufacture?

Accepted Answer

What regulatory product categories does Formulated Solutions support?

Formulated Solutions develops and manufactures products across multiple regulated healthcare and consumer product categories, including:

OTC Monograph Products
OTC NDA Products
Prescription (Rx) Pharmaceuticals
Medical Devices
Cosmetics

Our integrated CDMO capabilities include formulation development, analytical testing, regulatory support, scale-up, commercial manufacturing, and packaging. We work closely with customers to bring products to market across a wide variety of therapeutic categories, dosage forms, and delivery systems.

Question 36

Do you manufacture topical creams?

Accepted Answer

Yes. Formulated Solutions manufactures topical creams for prescription, OTC, and consumer healthcare applications. Our integrated CDMO services include formulation development, process optimization, commercial manufacturing, filling, packaging, and quality support to help customers bring high-quality products to market.

Question 37

Do you manufacture topical lotions?

Accepted Answer

Yes. Formulated Solutions manufactures topical lotions designed for pharmaceutical, cosmetic, and personal care markets. We provide formulation expertise, analytical support, commercial manufacturing, packaging, and regulatory guidance to help customers successfully develop and commercialize their products.

Question 38

Do you manufacture topical gels?

Accepted Answer

Yes. Formulated Solutions develops and manufactures topical gel formulations for a variety of regulated healthcare and consumer applications. Our experience includes formulation development, stability testing, scale-up, commercial manufacturing, and packaging.

Question 39

Do you manufacture topical ointments?

Accepted Answer

Yes. Formulated Solutions manufactures topical ointments for pharmaceutical and OTC applications while supporting customers through formulation development, analytical testing, commercial manufacturing, packaging, and regulatory support.

Question 40

Do you manufacture topical foams?

Accepted Answer

Yes. Formulated Solutions develops and manufactures topical foams for prescription, OTC, and consumer healthcare markets. We help customers develop innovative foam formulations while supporting scale-up, commercial manufacturing, packaging, and quality management throughout the product lifecycle.

Question 41

Can Formulated Solutions manufacture prescription and OTC topical products?

Accepted Answer

Yes. Formulated Solutions manufactures both prescription and OTC topical products in FDA-registered, cGMP-compliant facilities. Our integrated development and manufacturing capabilities help customers successfully navigate formulation, analytical testing, validation, manufacturing, packaging, and commercialization.

Question 42

What nasal drug delivery products does Formulated Solutions manufacture?

Accepted Answer

What regulatory product categories does Formulated Solutions support?

Formulated Solutions develops and manufactures products across multiple regulated healthcare and consumer product categories, including:

OTC Monograph Products
OTC NDA Products
Prescription (Rx) Pharmaceuticals
Medical Devices
Cosmetics

Our integrated CDMO capabilities include formulation development, analytical testing, regulatory support, scale-up, commercial manufacturing, and packaging. We work closely with customers to bring products to market across a wide variety of therapeutic categories, dosage forms, and delivery systems.

Question 43

Do you manufacture metered-dose nasal sprays?

Accepted Answer

Yes. Formulated Solutions manufactures metered-dose nasal spray products designed to deliver consistent and accurate dosing. Our integrated CDMO services include formulation development, device compatibility evaluation, analytical testing, commercial manufacturing, and packaging to support successful product commercialization.

Question 44

Do you manufacture squeeze nasal spray products?

Accepted Answer

Yes. Formulated Solutions develops and manufactures squeeze nasal spray products for pharmaceutical and OTC markets. We help customers optimize formulation performance, packaging compatibility, manufacturing processes, and regulatory compliance throughout development and commercialization.

Question 45

Can Formulated Solutions manufacture prescription and OTC nasal products?

Accepted Answer

Yes. Formulated Solutions manufactures both prescription and OTC nasal products in FDA-registered, cGMP-compliant facilities. Our experienced development and manufacturing teams support customers from formulation and analytical testing through validation, commercial manufacturing, packaging, and ongoing supply.

Question 46

How does Formulated Solutions support nasal product development?

Accepted Answer

Formulated Solutions provides end-to-end support for nasal product development, including formulation development, analytical method development, stability testing, process optimization, scale-up, commercial manufacturing, packaging, and regulatory support. Our collaborative approach helps customers efficiently advance products from concept through commercialization.

Question 47

What packaging formats does Formulated Solutions support?

Accepted Answer

Formulated Solutions supports a wide range of primary packaging formats for pharmaceutical, OTC, cosmetic, and medical device products, including bottles, jars, standard and metered-dose pumps, tubes, aerosol cans, bag-on-valve systems, and nasal delivery units. We work with customers to match packaging and delivery systems to formulation, regulatory, and brand requirements from early development through commercial launch.

Question 48

Do you manufacture and fill products in bottles?

Accepted Answer

Yes. Formulated Solutions fills and packages products in a variety of bottle formats, including HDPE, PET, and post-consumer recycled (PCR) options. Our filling lines support liquids, semi-solids, and pump- or spray-dispensed formulations, with packaging selected to protect product stability and meet regulatory and brand requirements.

Question 49

Do you manufacture and fill products in jars?

Accepted Answer

Yes. Formulated Solutions fills and packages products in jars for creams, ointments, gels, and other semi-solid formulations. Our packaging teams work with customers to select jar materials and closures that support product stability, usability, and shelf presentation.

Question 50

Do you offer metered-dose pump packaging?

Accepted Answer

Yes. Formulated Solutions offers metered-dose pump packaging designed to deliver consistent, accurate dosing for topical, oral liquid, and nasal products. We evaluate pump and formulation compatibility during development to help ensure reliable performance from first use through the end of the product's shelf life.

Question 51

Do you offer standard pump packaging?

Accepted Answer

Yes. Formulated Solutions offers standard, non-metered pump packaging for lotions, creams, gels, and other liquid and semi-solid products. Standard pumps are commonly used where consistent, high-volume dispensing is needed without the precision-dose requirements of a metered system, and our team helps determine the right fit based on product viscosity and use case.

Question 52

How does Formulated Solutions help customers select the right delivery system for their product?

Accepted Answer

Formulated Solutions works with customers early in development to evaluate delivery system options, including bottles, jars, standard and metered-dose pumps, aerosols, bag-on-valve, and nasal formats, based on formulation characteristics, target dose or usage pattern, regulatory pathway, and brand positioning. This consultative approach helps ensure the packaging and delivery system selected supports both product performance and commercial success.